Lower riskMedical device recall · FDA · Published December 14, 2020
Integra Bactiseal Ventricular Catheter Mislabeled - Risk of Wrong Product Used
Integra LifeSciences recalls Bactise:al Ventricular Catheter (823073) mislabeled as Bactiseal Endoscopic Ventricular Catheter (823087). This could lead to incorrect use in hydrocephalus treatment. Affected units: Lot 4178253, exp. Nov 2019.
Mislabeled product-Bactiseal Ventricular Catheter with Bactiseal Shunt System(823073) mislabeled as Bactiseal Endoscopic Ventricular Catheter (823087) and vs. versa
“Integra Bactiseal Ventricular Catheter Mislabeled - Risk of Wrong Product Used.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63665-integra-bactiseal-ventricular-catheter-mislabeled-risk-of-wrong-product-used. Based on FDA recall #Z-0724-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0724-2021%22&limit=1).
Integra LifeSciences Corp. recalled the Bactiseal Ventricular Catheter with Bactiseal Shunt System on Dec. 14, 2020, due to mislabeling risks, according to the FDA. The Food and Drug Administration announced the Class II recall of 85 units distributed nationwide.
How to tell if you have it
Brand: Integra LifeSciences
Product: Bactiseal Ventricular Catheter with Bactiseal Shunt System
Part Number: 823073
Lot Number: 4178253
Expiration Date: November 2019
The hazard
The Bactiseal Ventricular Catheter with Bactiseal Shunt System (Part No. 823073) was mislabeled as the Bactiseal Endoscopic Ventricular Catheter (Part No. 823087), and vice versa, according to the FDA.
Context
GovInfoNow's records show Integra LifeSciences Corp. has 35 other recalls on record since Aug. 18, 2017. Other recent recalls of similar products include Codman CerebroFlo EVD Catheter Recall (April 10, 2026), Boston Scientific FARASTAR PFA Generator Recall (June 11, 2026) and Bard PowerMidline Catheter Recall (May 21, 2026).
How to tell if you have this one
Check for part number 823073 on the catheter. The lot number 4178253 was produced for expiration November 2019. This product is used for hydrocephalus treatment.
Brand
Integra LifeSciences
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
US Nationwide distribution.
Recall number
Product, codes & lots
Quantity
Z-0724-2021
Bactiseal Ventricular Catheter with Bactiseal Shunt System - Product Usage: use in the treatment of hydrocephalus as a component of a shunt system when draining or shunting cerebrospinal fluid (CSF) Part Number: 823073; Lot Number: 4178253 Exp. Date: November 2019
85 units
Z-0725-2021
Bactiseal Endoscopic Ventricular Catheter: EVC- Catheter is designed for use in the treatment of hydrocephalus when shunting cerebrospinal fluid (CSF) from the ventricles of the brain. Part Number: 823087; Lot Number:4178257 Exp. Date: November 2019
17 units
Based on the official FDA remedy
What to do — step by step
Check Product Label
Look for part number 823073 and lot number 4178253 on the catheter.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 7 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0724-2021 (December 14, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0724-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.